# K980379: Prowess Pro-Sim

- Pathway: 510(k) (Traditional)
- Applicant: Ssgi Prowess Systems
- Decided: May 18, 1998 after 108 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862643 (1987). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921991: Plato Radiation Therapy Planning System, Nucletron-Oldelft Corp. (1992) Summary page 1.
- K970236: Theraplan Plus Version 1.2, Theratronics, Inc. (1997) Summary page 1.
- K923851: Acqsim Simulator/Localizer, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 1.
- K862643: Radiation Oncology Computer Sys Treatment Planning, Pacific Physics, Inc. (1987) Summary page 1.

## Most influential descendants
- K032456: Prowess (2003), 0 descendants of its own
- K992689: MU Plus (2000), 0 descendants of its own
- K984196: Modification to Prowess Pro-Sim (1998), 0 descendants of its own

## Indications for use
Prowess Pro-Sim is a modularly designed Radiation Treatment Planning Computer Program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can be simulated using Prowess Pro-Sim in 3D on the computer’s display prior to actual treatment. Prowess Pro-Sim acquires CT and MR image data from a variety of DICOM compliant sources via its server module called APEX. MRI and CT machine data is acquired in a standard format from a variety of sources and stored in a database. Prowess Pro-Sim is used to contour and simulate radiation treatment therapy. Depending on the type of therapy, contouring information is passed from the Prowess Pro-Sim module to the Prowess 500 module for Brachytherapy planning or the Prowess 3000 module for External Beam planning. Once planning is complete, plans can be saved on the computer and printed using a variety of printers.

Source page: https://510kreport.com/device/K980379
Methodology: https://510kreport.com/methodology